Methadone maintenance in primary care: a randomized controlled trial.

CONTEXT Methadone maintenance is an effective treatment for opioid dependence, yet its use is restricted to federally licensed narcotic treatment programs (NTPs). Office-based care of stabilized methadone maintenance patients is a promising alternative but no data are available from controlled trials regarding this type of program. OBJECTIVE To determine the feasibility and efficacy of office-based methadone maintenance by primary care physicians vs in an NTP for stable opioid-dependent patients. DESIGN Six-month, randomized controlled open clinical trial conducted February 1999-March 2000. SETTING Offices of 6 primary care internists and an NTP. PATIENTS Forty-seven opioid-dependent patients who had been receiving methadone maintenance therapy in an NTP without evidence of illicit drug use for 1 year and without significant untreated psychiatric comorbidity were randomized; 1 patient refused to participate after treatment assignment to NTP. INTERVENTIONS Patients were randomly assigned to receive office-based methadone maintenance from primary care physicians, who received specialized training in the care of opioid-dependent patients (n = 22), or usual care at an NTP (n = 24). MAIN OUTCOME MEASURES Illicit drug use, clinical instability (persistent drug use), patient and clinician satisfaction, functional status, and use of health, legal, and social services, compared between the 2 groups. RESULTS Eleven of 22 (50%; 95% confidence interval [CI], 29%-71%) patients in office-based care compared with 9 of 24 (38%; 95% CI, 21%-57%) of NTP patients had a self-report or urine toxicology test result indicating illicit opiate use (P =.39). Hair toxicology testing detected an additional 2 patients in each treatment group with evidence of illicit drug use, but this did not change the overall findings. Ongoing illicit drug use meeting criteria for clinical instability occurred in 4 of 22 (18%; 95% CI, 7%-39%) patients in office-based care compared with 5 of 24 (21%; 95% CI, 9%-41%) NTP patients (P =.82). Sixteen of the 22 (73%; 95% CI, 54%-92%) office-based patients compared with 3 of the 24 (13%; 95% CI, 0%-26%) NTP patients thought the quality of care was excellent (P =.001). There were no differences over time within or between groups in functional status or use of health, legal, or social services. CONCLUSIONS Our results support the feasibility and efficacy of transferring stable opioid-dependent patients receiving methadone maintenance to primary care physicians' offices for continuing treatment and suggest guidelines for identifying patients and clinical monitoring.